Catheter deployment device

ABSTRACT

An apparatus for deploying a needle within a lumen is provided. The apparatus includes a housing having a threaded bushing radially disposed therein. The bushing rigidly couples with a nose cone having a guide tip disposed at an end opposite the bushing for penetrating an arterial wall of a lumen. During operation, a user incrementally advances the bushing within the housing, thereby incrementally advancing the guide tip into the lumen. The nose cone also includes a flex guide having a slot configuration which couples with the guide tip which deploys into the lumen along with the guide tip.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/744,087, filed May 3, 2007, entitled “Catheter Deployment Device”,now U.S. Pat. No. 7,878,986, which is a continuation of U.S. patentapplication Ser. No. 10/736,459, filed Dec. 15, 2003, entitled “CatheterDeployment Device”, now U.S. Pat. No. 7,229,421, which is a continuationof U.S. patent application Ser. No. 10/005,981, filed Dec. 7, 2001,entitled “Catheter Deployment Device”, now U.S. Pat. No. 6,663,577, thedisclosures of which are incorporated herein by this reference.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to catheters and moreparticularly to a device which provides controlled delivery of a guidetip of a catheter within a lumen having chronic total occlusion.

2. The Relevant Technology

Cardiovascular disease is a leading cause of mortality worldwide. Oftentimes, cardiovascular disease occurs upon chronic total occlusion (CTO)of an artery of a patient. CTO typically occurs after a patient developsatherosclerosis. Blockage of an artery may occur in coronary, peripheralor other arteries. As the blockage continues over time, the blockagebecomes chronic, thereby leading to CTO.

In order to minimize the potential effects of CTO, passage of blood mustbe restored to the artery. In the past, attempts to restore blood flowincluded passing a guidewire through the occlusion, thereby forming apassage through which blood may flow. Nonetheless, while attempting topenetrate the occlusion, the guidewire may inadvertently penetrate asubintimal space between the intimal layer and the adventitial layer ofthe blood vessel. Once this occurs, redirection of the guidewire backinto the blood vessel lumen is nearly impossible. Therefore, the usermust pull the guidewire from the subintimal space and start theprocedure over thereby increasing the time and overall costs associatedwith returning blood passage to the artery having CTO.

Moreover, during insertion of the guidewire into the lumen, theconfiguration of prior art catheter devices allowed for accidentaldeployment of the guidewire during manipulation of the catheter device.As described in U.S. Pat. No. 6,217,527, the disclosure of which ishereby incorporated by reference, the motion required to deploy aguidewire from a prior art catheter device was the same as the motionfor inserting the catheter device into a lumen. To further illustrate, auser introduces a prior art catheter device into the vasculature of apatient using a lateral motion relative to the catheter device. Uponinsertion of the catheter device into the arterial lumen, the userdeploys the guidewire within the lumen using the same lateral motionrelative to the catheter device. As such, during the operation ofinserting the catheter device into the lumen, the user may accidentallydeploy the guide, thereby potentially damaging the lumen.

In addition to passing a guidewire through the occlusion, past attemptshave included forming a subintimal lumen through the subintimal space ofthe lumen. A user employing this method passes a guidewire between theintima and the adventitia of the lumen. Once the guidewire passesthrough the subintimal space, the user dissects the subintinal spacewith an angioplasty balloon and then performs a stenting operation. Uponstenting, an acceptable lumen is formed which bypasses the CTOaltogether.

As disclosed in U.S. Pat. No. 6,217,527, a user inserts a guidewire intothe subintimal space on one side of the occlusion. Upon insertion of theguidewire, the user inserts a catheter over the guidewire into thesubintimal space. The catheter includes a tip configured for penetratinga portion of the arterial wall at a distal side of the occlusion.However, the user must accurately deploy the guide tip within the lumenin order to avoid damaging an arterial wall of the lumen. For example,the user may over deploy the catheter such that the guide tip penetratesthe subintimal space, passes through the intended lumen and contacts thearterial wall on the opposite side of the intended lumen, therebypotentially injuring the patient. In addition, prior art guide tips wereconstructed of flexible material which decreased penetrationcapabilities of the guide tip through the subintimal space.

Accordingly, a need exists for an automated device which allows preciseadvancement of a guide tip deployed within a subintimal space of apatient. This new device should include a guide tip resistant toimparted bending forces during penetration of a subintimal space of anarterial wall. The new device should also minimize the possibility ofinadvertent deployment of a guide tip during use of the device.

BRIEF SUMMARY OF THE INVENTION

The present invention fills the aforementioned needs by providing acatheter device which incrementally advances a guide tip through asubintimal space of a patient. The present invention also provides amethod for incrementally advancing a guide tip through a subintimalspace of a patient.

In an embodiment of the present invention, a device for advancing aguide tip through a lumen is disclosed. The device includes a housinghaving a radial groove, a bushing and an inner key. The bushing isdisposed within the housing and operatively couples with the housing viaa bushing thread such that the bushing incrementally advances within thehousing. The inner key couples with both the bushing at a proximal endof the inner key and a guide tip via a braided shaft at a distal end ofthe inner key. The guide tip couples with the inner key such that as thebushing incrementally advances within the housing, the guide tipincrementally advances within the lumen. In addition, a flex guidehaving a slot configuration couples with the guide tip such that theflex guide also deploys into the lumen during use of the catheterdevice.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Many advantages of the present invention will be apparent to thoseskilled in the art with a reading of this specification in conjunctionwith the attached drawings, wherein like reference numerals are appliedto like elements and wherein:

FIG. 1 illustrates a lumen of a patient having an occlusion inaccordance with an embodiment of the present invention.

FIG. 2A is a perspective view illustrating an actuator handle of acatheter device in accordance with one embodiment of the presentinvention.

FIG. 2B is an embodiment of the present invention illustrating aschematic view of a shaft adapter of the catheter device shown withrespect to FIG. 2A.

FIG. 2C is a front view of the shaft adapter shown with reference toFIG. 2B in accordance with an embodiment of the present invention.

FIG. 3A shows a schematic view of the actuator handle shown withreference to FIG. 2A in accordance with one embodiment of the presentinvention.

FIG. 3B illustrates a schematic view of the present invention showing abushing thread of a bushing of the actuator handle shown with referenceto FIG. 3A.

FIG. 4A shows a schematic view illustrating an alternative embodiment ofthe catheter device shown with reference to FIG. 2A.

FIG. 4B illustrates a compression spring within a seat of a bushing ofthe catheter device shown with reference to FIG. 4A in accordance withan embodiment of the present invention.

FIG. 4C is an embodiment of the present invention illustrating a frontview of a firing assembly for the catheter device shown with referenceto FIG. 4A.

FIG. 4D is a front view of the firing mechanism shown with reference toFIG. 4C where the firing mechanism is in a fired position in accordancewith an embodiment of the present invention.

FIG. 4E is a side view of the firing mechanism shown with respect toFIG. 4D in accordance with an embodiment of the present invention.

FIG. 5A illustrates a schematic view of a catheter device in accordancewith an alternative embodiment of the present invention.

FIG. 5B is a schematic view of the catheter device shown with respect toFIG. 5A where a left handle of the catheter device has been omitted inaccordance with an embodiment of the present invention.

FIG. 5C shows a schematic view of the catheter device shown withreference to FIG. 5A in a deployed position in accordance with anembodiment of the present invention.

FIG. 5D illustrates a perspective view of a stepped hub of the catheterdevice shown with reference to FIG. 5B in accordance with an embodimentof the present invention.

FIG. 5E is an embodiment of the present invention illustrating a methodfor locking a button and an actuator of the catheter device shown withrespect to FIG. 5B into a position shown with respect to FIG. 5C.

FIG. 6A is a schematic view of the guide tip shown with reference toFIG. 1 in accordance with an embodiment of the present invention.

FIG. 6B is a perspective view of the guide tip shown with reference toFIG. 6A where a guide tip and a flex guide are in a deployed position inaccordance with an embodiment of the present invention.

FIG. 6C illustrates a schematic view of an alternative embodiment of aflex guide in accordance with an embodiment of the present invention.

FIG. 6D shows a perspective of an alternative embodiment for thecatheter device shown with reference to FIGS. 2A and 5A.

FIG. 6E illustrates a perspective view of a guide tip which includes aplurality of tips in accordance with an embodiment of the presentinvention.

FIG. 7 shows a schematic view of an embodiment of the present inventionwhere the catheter device shown with reference to FIG. 2A includes aballoon.

FIG. 8A shows a schematic view of the catheter device shown withreference to FIG. 2A where the catheter device includes anchors foranchoring a guide tip within a subintimal space of a lumen in accordancewith an embodiment of the present invention.

FIG. 8B illustrates a schematic view of spacers and anchors disposedwithin the catheter device shown with reference to FIG. 8A in accordancewith an embodiment of the present invention.

FIG. 8C shows a schematic view of the spacers and the anchors shown withrespect to FIG. 8B in a deployed position in accordance with anembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

A device which provides precise movement of a guide tip within a lumenis disclosed. As an overview, the present invention discloses a devicewhich controls a guide tip through a lumen, such as a blood vessel or anartery, of a patient. The device controls the guide tip while a user,such as a surgeon, crosses an occlusion within an artery of a patient inorder to allow blood flow through the artery. The device includes ahousing having a guide and bushing disposed within the housing. Theconfiguration of the bushing allows for travel of the bushing along theguide within the housing. In accordance with one embodiment of thepresent invention, the guide within the housing includes grooves and theconfiguration of the bushing also includes threads complementary to thegrooves in the housing such that the threads in the housing guide thebushing. During use of the device, a user rotates a knob which moves thebushing along the grooves within the housing. As will be discussed ingreater detail with respect to the accompanying Figures, when the useradvances the bushing within the housing, the bushing advances the guidehaving a guide tip attached to a distal end thereof, thereby moving theguide tip within the lumen of the patient.

Now making references to the Figures, and more particularly FIG. 1, FIG.1 illustrates a lumen 161 of a patient having an occlusion 162. Aspreviously described with reference to the background, the occlusion maybe caused in any number of ways, including atherosclerosis. As may beseen with reference to FIG. 1, the occlusion 162 prevents blood passageas indicated by directional arrows BP from a side 161 a of the occlusion162 within the lumen 161 to a side 161 b of the occlusion 162.Therefore, a user inserts a catheter 101 of a catheter device 100 (shownwith reference to FIG. 2A) through the lumen 161 on the side 161 a andinto a subintimal space defined by an intima layer 164. Upon bypassingthe occlusion 162 through the subintimal space 164, a user deploys aflex guide 134 along with a guide tip 132 through the arterial wall andinto the lumen 161 on side 161 b of the occlusion. The user deploys boththe guide tip 132 and the flex guide 134 with the catheter device 100shown with reference to FIG. 2A.

FIG. 2A is a perspective view illustrating an actuator handle 102 of thecatheter device 100 in accordance with one embodiment of the presentinvention. The catheter device 100 includes the catheter 101, an innerkey 108, a nose cone 130, the guide tip 132 and the flex guide 134 (allshown with reference to FIG. 6A). The inner key 108 includes a braidedtube 109 about which the catheter 101 axially disposes. In accordancewith one embodiment of the present invention, the catheter 101 may havea length in a range preferably between about 80 cm and about 120 cm andmore preferably have a length of about 100 cm. In the preferredembodiment, having a length of 100 cm allows performance of a peripheralvascular intervention procedure using a contralateral approach. Inaddition, the catheter 101 may also be coated with a hydrophilic coatingwhich provides lubrication for the catheter 101, thereby increasing theease of operation of the catheter 101 within a patient. Moreover, inthis embodiment, the catheter 101 may be constructed from a polyimideand polyurethane tube with braided stainless steel wire. In addition,the catheter 101 encompasses a full length central lumen which is sizedto accept a guidewire. In various embodiments of the present invention,the central lumen of the catheter 101 may accept a 0.035 inch or smallerguidewire. In a preferred embodiment of the present invention, thecentral lumen of the catheter 101 accepts a 0.035 inch guidewire.

The housing 102 and the braided tube 109 couple with the nose cone 130.As such, the braided tube 109 couples the housing 102 with the nose cone130. In one embodiment of the present invention, the braided tube 109may be constructed from a stainless steel braided polymide shaft. Thecatheter device 100 also includes a shaft adapter 136 as more clearlyshown with reference to FIG. 2B.

FIG. 2B shows an embodiment of the present invention illustrating aschematic view of the shaft adapter 136 of the catheter device 100,shown with respect to FIG. 2A. The shaft adapter 136 maintains a tighttolerance for an inner key 108 and prevents buckling of the braided tube109 disposed within the inner key 108. In accordance with an embodimentof the present invention, the shaft adapter 136 may be constructed ofpolycarbonate or any other known plastic. The shaft adapter 136 alsoincludes a guide 136 a which steadies the inner key 108 within thecatheter device 100 and a lumen of a patient. In accordance with anembodiment of the present invention, a portion of the inner key 108which extends through the housing 102 and a rotating hemostasis valve112 has a circular configuration. However, as the inner key 108 entersthe guide 136 a of the shaft adapter 136 a, the configuration of theinner key 108 changes, as shown with respect to FIG. 2C.

FIG. 2C is a schematic view of the inner key 108 within the guide 136 aand the shaft adapter 136 shown with reference to FIG. 2B in accordancewith an embodiment of the present invention. As may be seen withreference to the Figure, the inner key 108 includes surfaces 108 ahaving a planar configuration abutting a surface 136 a-1 of the guide136 a. As such, the guide 136 a controls rotation of the inner key 108during use of the catheter device 100, thereby controlling rotation ofthe guide tip 132 and the braided tube 109. To further illustrate,rotation of the guide 136 a rotates the inner key 108 along with thebraided tube 109. As the braided tube 109 rotates within the catheter101, the flex guide 132 also rotates. Therefore, if a user determinesthat the nose cone 130 (shown with reference to FIG. 6A) must be rotatedduring procedure, the user rotates the guide 136 a, thereby rotating theinner key 108 and the guide tip 132. It should be noted that the innerkey 108 may also rotate the guide 136 a using the surfaces 108 a.Returning attention to FIG. 2A and the catheter device 100, theconfiguration of the actuator handle 102 allows for precise, incrementaladvancement of the guide tip 132 within the arterial wall and lumen of apatient, as further described with reference to FIG. 3A.

FIG. 3A shows a schematic view of the actuator handle 102 shown withreference to FIG. 2A in accordance with one embodiment of the presentinvention. The actuator handle 102 includes a housing 104 and a bushing110. In an embodiment of the present invention, the housing 104 maybeconstructed using any high strength, durable material, such as plasticor the like. It should be noted that in an embodiment of the presentinvention, the housing 104 functions as a depth actuating knob (DAK) inorder to control the amount of deployment of the guide tip 132 within alumen. The housing 104 includes a groove 104 a which allows travel ofthe bushing 110 within the housing 104 during use of the catheter device100. As may be seen with reference to the Figure, the groove 104 a isspirally disposed about an inner wall 104 b of the housing 104. Thegroove 104 a complements a bushing thread 110 a disposed on the bushing110, as shown with reference to FIG. 3B.

FIG. 3B is a schematic view of the present invention showing a bushingthread 110 a of the bushing 110 shown with reference to FIG. 3A. Thebushing thread 110 a runs along a periphery of the bushing 110 such thatthe bushing 110 contacts the housing 104 and the groove 104 a via thebushing thread 110 a. As such, the bushing thread 110 a allows forprecise movement of the bushing 110 within the housing 104 duringadvancement and retraction of the guide tip 132. Therefore, when a userelects to either advance or retract the guide tip 132 within a lumen,the user moves the bushing 110 within the housing 104 via the groove 104a and the bushing thread 110 a by rotating the housing 104 a.

Returning attention to FIG. 3A, the actuator handle 102 also includes arotating hemostasis valve adapter 116. The rotating hemostasis valveadapter 116 integrates the housing 104 and the inner key 108 with therotating hemostasis valve (RHV) 112. The RHV 112 may be any rotatinghemo stasis valve which provides an interface between the rotatinghemostasis valve adapter 116 and the inner key 108 such as a rotatinghemostasis valve available from Merit Medical located in South Jordan,Utah, or the like. The RHV 112 also minimizes the possibility ofbuckling by the braided tube 109 during use of the catheter device 100.It should also be noted that the RHV 112 changes the direction of thenose cone 130 during operation of the catheter device 100, therebychanging the direction of the guide tip 132 and the flex guide 134. TheRHV 112 may rotate 360 degrees, thereby allowing full control of thenose cone 130 and the guide tip 132.

In addition to the rotating hemostasis valve adapter 116, the actuatorhandle 102 also includes the inner key 108. The inner key 108 includesflanges 120 which reside within a cavity 110 b of the bushing 110. In apreferred embodiment, the flanges 120 have a flush fit within the cavity110 b. Thus, when the bushing 110 advances or retracts within thehousing 104, the flange 120 moves along with the bushing 10, therebymoving the inner key 108. As will be discussed in greater with referenceto FIG. 6A, the braided tube 109 couples with the guide tip 132. As thebushing 110 advances the inner key 108, both the guide tip 132 and theflex guide 134 advance into the side 161 b of the lumen 161, as shownwith reference to FIG. 1. As such, the catheter device 100 allowsprecise, incremental advancement of the guide tip 132 and the flex guide134 within the lumen 161.

The actuator handle 102 also includes a compression seal 114 whichprovides a seal between the inner key 108 and both the rotatinghemostasis valve adapter 116 and the housing 104. The compression seal114 provides sealing engagement between the RHV 112 and the rotatinghemostasis valve adapter 116. The compression seal 114 preventscontamination of the housing 104 and the rotating hemostasis valveadapter 116 via the inner key 108.

Now making reference to FIG. 4A, FIG. 4A shows a schematic viewillustrating an alternative embodiment of the catheter device 100 shownwith reference to FIG. 2A. In this embodiment, the catheter device 100includes a firing mechanism which provides automated deployment using acontrolled force of the guide tip 132 within a lumen of a patient duringoperation of the catheter device 100. In this embodiment, the catheterdevice 100 includes a compression spring 128, as more clearly shown withreference to FIG. 4B. FIG. 4B illustrates the compression spring 128within a seat 126 of the bushing 110. The compression spring 128compresses between a surface 126 a of the seat 126 and a tab 108 b ofthe inner key 108. The compression spring 128 may be any compressionspring capable of imparting a force to the flex guide 132 preferably ina range between about 0.8 lbs and about 2.5 lbs and more preferablyabout 2.0 lbs. As such, the catheter device 100 provides the necessaryforce for penetration of an arterial wall of a lumen of a patient.

Turning attention to FIG. 4C a firing assembly formed by a safety pin122 and a key 124 compresses the compression spring 128 until activationby a user. The key 124 includes keyholes 124 a and 124 b where thekeyhole 124 a has a diameter smaller than a diameter of the inner key108. Therefore, the keyhole 124 a holds the inner key 108 in place priorto the deployment of the guide tip 132. The keyhole 124 b has a diameterlarger than the diameter of the inner key 108. Thus, upon entering thekeyhole 124 b, the inner key 108 advances, thereby deploying the guidetip 132 and the flex guide 134 within a lumen of a patient.

Prior to the deployment of the guide tip 132, the inner key 108 resideswithin the keyhole 124 a (as more clearly shown with reference to FIG.4C) of the key 124. The safety pin 122, which includes an “L”configuration as shown with reference to the Figure, maintains the innerkey 108 within the keyhole 124 a during inoperation of the catheterdevice 100. A user engages the firing assembly by moving the safety pin122 in a direction X₁ as indicated by directional arrow X₁. After theuser moves the safety pin 122 in the direction X₁, the user then movesthe key 124 in a direction X such that the inner key 108 moves from thekey hole 124 a to the key hole 124 b, as shown with reference to FIG.4D. As may be seen with respect to FIG. 4D, the keyhole 124 b has alarger diameter than the inner key 108. As such, the compression spring128 moves the inner key 108 in the direction X₁ (shown with reference toFIG. 4E) when the inner key 108 enters the keyhole 124 b, therebydeploying the guide tip 132 through an arterial wall of a lumen of apatient.

As described with reference to the background, the motion required todeploy the guidewire from prior art catheter devices was the same as themotion used to insert the catheter device into a lumen. For example,making reference to FIG. 4A, a user inserted prior art catheter devicesinto a patient in the direction X₁. Upon insertion into the lumen, theuser deployed a prior art guidewire by moving a plunger disposed at anend of the prior art catheter device in the same direction X₁. As may beappreciated, the user may accidentally deploy the prior art guidewireduring insertion of the catheter device since the same motion was usedto insert the prior art catheter device into the patient and then deploythe guidewire. The present invention avoids this problem since the userrotates the housing 104 in order to deploy the guide tip 132 within alumen of a patient after inserting the catheter device in the directionX₁, as previously described.

In addition, the present invention minimizes the possibility of backingout the guide tip from the catheter device during retraction of thecatheter device 100 and the guide tip 132 from the patient. Aspreviously described, the guide tip 132 couples with the bushing 110 viathe braided tube 109. The bushing 110 within the housing 104 remainsfixed within the housing 104 due to the engagement between the threads110 a of the bushing 110 with the groove 104 a of the housing 104. Assuch, as the catheter device 100 moves in the direction Y₁ out of thelumen of the patient, the guide tip 132 also moves in the direction Y₁.

Now making reference to FIG. 5A, FIG. 5A illustrates a schematic view ofa catheter device 138 in accordance with an alternative embodiment ofthe present invention. In this embodiment, the catheter device 138includes a left handle 142 a and a right handle 142 b, a button 140 anda port 141. The catheter device 138 also includes an inner key 144 and alure 145 which allows a user to lead the catheter 101 which couples withthe inner key 144, during operation of the catheter device 138. As maybe seen with reference to the Figure, a configuration of the left handle142 a, similar to that of the right handle 142 b, allows for easymanipulation by a user as the user performs a procedure. As will bediscussed in greater detail with reference to FIG. 5B, the button 140advances the inner key 144 during operation of the catheter device 138.The inner key 144 couples with the braided shaft 109, the flex guide 134and the guide tip 132, as previously described with reference to theinner key 108. As such, in this embodiment, the inner key 144 of thecatheter device 138 includes the same functionality of the inner key 108of the catheter device 100. In addition to the inner key 144, thecatheter device 138 also includes the port 141. The port 141 allows forthe addition of a fluid, such as saline solution, during operation ofthe catheter device 138 in order to minimize the presence of air bubbleswithin the catheter 101 and flush out the catheter 101 prior to use ofthe catheter device 100.

Now making reference to FIG. 5B, FIG. 5B is a schematic view of thecatheter device 138 shown with respect to FIG. 5A without the lefthandle 142 a in accordance with an embodiment of the present invention.The catheter device 138 also includes an actuator 146 rigidly coupledwith the inner key 144 which extends from both sides of the actuator146, as may be seen with reference to the Figure. The catheter device138 also includes a compression spring 148 disposed coaxially about theinner key 144 between a surface 146 b of the actuator 146 and a surface150 a of a rotating hub 150. During inoperation of the catheter device138 the compression spring 148 maintains both the inner key 144 and theactuator 146 in a fixed, non-deployed position, where the button 140 ismaintained in an upward position, as shown with reference to the Figure.In the embodiment of the invention shown with reference to FIG. 5B, thecatheter device 138 includes the rotating hub 150 for adjusting theposition of the nose cone 130. A user may use the rotating knob 150 torotate the nose cone 130 in order to allow for precise penetration of anarterial wall of a lumen. It should be noted that in alternativeembodiment of the catheter device 138, the catheter device 138 includesa rotating knob 152 as shown with respect to FIG. 5C. In thisembodiment, the rotating knob 152 includes the same functionality as therotating knob 150. Thus, a user rotates both the guide tip 132 and theflex guide 134 by rotating the rotating knob 152.

The catheter device 138 also includes the actuator 146 having gradients146 a which complement gradients 140 a of the button 140. The buttongradients 140 a complement the actuator gradients 146 a such that as auser moves the button 140 in a direction Y as indicated by directionalarrow Y, the button gradients 140 a slide along the actuator gradients146 a. As a user moves the button 140 in the direction Y into aconfiguration shown with respect to FIG. 5C, the actuator 146 moves inthe direction Y₁. It should be noted that in this embodiment, the button140 remains fixed with respect to the right handle 142 b. Thus, when thebutton gradients 140 a engage with the actuator gradients 146 a, theengagement causes movement of the actuator 146 and the inner key 144 inthe direction Y₁. As previously described, the inner key 144 coupleswith the flex guide 144 and the guide tip 132 via the braided tube 109.As such, motion of the inner key 144 in the direction Y₁ causesdeployment of the flex guide 134 and the guide tip 132.

In addition to the actuator 146, the catheter device 138 also includes ahub assembly having a stepped hub 156, a hub stop 158 and a hub rod 159rigidly coupled with the actuator 146. The hub assembly minimizes travelof the actuator 146 within the catheter device 138. When a user movesthe button 140 in the direction Y, the button 140 continues motion untilthe hub stop 158, which rigidly couples with the actuator 146, contactsthe stepped hub 156. When the hub stop 158 contacts the stepped hub 156,further motion of the button 140 and the guide tip 132 in the directionY is restricted. As discussed earlier, movement of the button 140 in thedirection Y controls deployment of the guide tip 132 and the flex guide134 within a lumen. To further illustrate, the greater the button 140moves in the direction Y, the greater deployment of the guide tip 132and the flex guide 134 since the button 140 couples with the inner key144. Therefore, as a result of controlling the motion of the button 140in the direction Y, the stepped hub 156 controls the deployment of theguide tip 132 and the flex guide 134 within a lumen. The stepped hub 156controls the amount of deployment with steps 156 a through 156 c as maybe seen with reference to FIG. 5D.

FIG. 5D is an embodiment of the present invention illustrating aperspective view of the stepped hub 156 shown with reference to FIG. 5B.The stepped hub 156 includes the steps 156 a through 156 c and anactuation knob 156 d. The hub stop 158 contacts one of the steps 156 athrough 156 c depending upon the orientation of the stepped hub 156within the catheter device 138. As may be seen with reference to theFigure, the steps 156 a through 156 c are disposed at varying depthsrelative to the one another. Therefore, a user controls the amount ofdeployment of the guide tip 132 and the flex guide 134 within a lumenvia the stepped hub 156. To further illustrate, in the embodiment shownwith reference to FIG. 5D, the step 156 c is at a greater depth than thestep 156 a as indicated by a dimension Z. The step 156 c permits greatertravel of the hub stop 158 during downward motion of the button 140.Therefore, in order to increase the deployment of the guide tip 132 andthe flex guide 134 within a lumen of a patient, a user rotates theactuation knob 156 d such that the hub stop 158 contacts the step 156 cto control deployment. Likewise, in this embodiment, a user may decreasethe amount of deployment of both the guide tip 132 and the flex guide134 by rotating the actuation knob 156 d such that the hub stop 158contacts either the steps 156 a or 156 b. It is to be understood thatthe hub assembly may include any number of steps which control theamount of deployment of the guide tip 132 and the flex guide 134 inaddition to the steps 156 a through 156 c shown with respect to FIG. 5D.

During operation of the catheter device 138, the button 140 and theactuator 146 remain in the position shown with respect to FIG. 5C with aratchet assembly shown with reference to FIG. 5E. FIG. 5E shows anembodiment of the present invention illustrating a method for lockingthe button 140 and the actuator 146 into the position shown withreference to FIG. 5C. The actuator 146 includes ratchets 160 having agradient 160 a and a surface 160 b which engage a stop 163 of a lock154. As previously mentioned, during operation of the catheter device138, a user moves the button 140 in the downward direction X. When theuser moves the button 140 in the downward direction X, the actuator 146moves in the direction Y₁. As the actuator 146 moves in the directionY₁, surfaces 160 a of the ratchets 160 slide over the stop 163. Thesurfaces 160 a continue sliding over the stop 163 until the hub stop 158engages with the hub assembly of the catheter device 138, as describedearlier. Upon engagement of the hub stop 158 with the hub assembly, thestop 163 engages with a surface 160 b of the ratchets 160, therebypreventing movement of the actuator 146 in the direction X₁ and lockingthe position of the guide tip 132 and the flex guide 134 within a lumenof a patient. The lock 154 includes a compression spring 154 b (moreclearly shown with reference to FIG. 5B) which imparts a force in thedirection Y, thereby maintaining engagement between the lock 154 and theactuator 146. Once the user completes a procedure using the catheterdevice 138, the user disengages the lock 154 by rotating the lock 154about pivot 154 a in a direction Y₂, as indicated by directional arrowY₂, which allows motion of the actuator 146 in the direction X₁.

Now making reference to FIG. 6A, FIG. 6A is a schematic view of the nosecone 130 shown with reference to FIG. 1 in accordance with an embodimentof the present invention. The nose cone 130 houses both the guide tip132 and the flex guide 134 prior to deployment of the guide tip 132 andthe flex guide 134 within a lumen. The nose cone 130 includes a lumen(not shown) which allows back loading of the catheter 101 over aguidewire. In an embodiment of the present invention, the lumen may besized to accept a guidewire. Guidewires are provided in many diameters,such as 0.018 inch or 0.035 inch, for instance. In a preferredembodiment, the lumen is sized to accept a 0.035 inch guidewire. Itshould also be noted that in this embodiment of the present invention,the nose cone 130, along with the guide tip 132 and the flex guide 134,may be radiopaque for visualization under a fluoroscope.

The nose cone 130 includes cam surfaces 130 a through 130 c which pivotthe guide tip 132 as the guide tip 132 deploys from the nose cone 130.In accordance with an embodiment of the present invention, the nose conecam surfaces 130 a may be formed at an angle H in a range preferablybetween about 20 degrees and about 50 degrees and more preferably about30 degrees. The guide tip 132 includes a cam surface 132 a, a curvedportion 132 b and a tip 132 d. The guide tip cam surface 132 a engageswith the nose cone cam surfaces 130 a through 130 c during deployment ofthe guide tip 132 from the nose cone 130. As previously discussed, wheneither the inner key 108 or the inner key 144 are engaged by a user,both the inner key 108 and the inner key 144 move the flex guide 134 andthe guide tip 132 in a direction Y₁. As the guide tip 132 moves in thedirection Y₁, the nose cone cam surface 132 a first contacts the guidetip cam surface 130 a such that the nose cone cam surface 130 a movesthe guide tip 132 in a direction X₂ as indicated by directional arrowX₂. The guide tip cam surface 132 a then contacts the nose cone camsurface 130 b, which further rotates the guide tip 132 in the directionX₂. Upon engagement with the guide tip cam surface 130 b, the guide tipcam surface 132 a then engages the nose cone cam surface 130 a, whichfurther rotates the guide tip 132 in the direction X₂ and orientates theguide tip 132 as shown with respect to FIG. 6B. It should be noted thatthe flex guide 134 follows the same path as the guide tip 132 such thatthe flex guide 134 also deploys from the nose cone 130 as shown withrespect to FIG. 6B.

During operation of the catheter devices 100 and 138, the tip 132 dpenetrates a lumen of a patient thereby allowing passage of the flexguide 134 into the lumen upon penetration. In an embodiment of thepresent invention, the guide tip 132 may be constructed from platinumiridium, stainless steel or any material being radiopaque and havinghigh strength properties having a high resisitivity to bending. Inaddition, the guide tip 132 may be a needle capable of penetrating of anarterial wall of a lumen.

In an embodiment of the present invention, the flex guide 134 may alsobe constructed from stainless steel or any similar material having highstrength properties. The flex guide 134 also includes cut-outs 134 adisposed throughout the flex guide 134 which increase the flexibility ofthe flex guide 134. The cut-outs 134 a are configured to control columnstrength of the flex guide 134 and allow flexing of the flex guide 134as the flex guide 134 deploys from the nose cone 130 and enters a lumenof a patient. In one embodiment of the present invention, the cut-outs134 a may have a multiple slot configuration as shown with reference toFIG. 6B. It should be noted that the slots of cut-outs 134 a may haveany configuration (i.e., E configuration, etc.) which allows bothcontrol of column strength and flexing. In accordance with analternative embodiment of the present invention, the flex guide 134 mayalso have the configuration shown with reference to FIG. 6C. In thisembodiment, a flex guide 134 a-1 has a bellows configuration where theflex guide includes a plurality of bellows 134 a-2 which allow flexingof the flew guide 134 a-1 during deployment of the guide tip 132. Inaddition, the bellows configuration of the flex guide 134 a-1 allowscontrol of column strength.

The slots may be formed in the flex guide 134 using any suitabletechnique for forming cut-outs in a high strength material, such aslaser cutting, electrical discharge machining, stamping or the like. Inthis embodiment, the cut-outs 134 a are continuously formed within theflex guide 134. Moreover, the cut-outs 134 a are formed 90 degreesrelative to one another as more clearly shown with reference to FIG. 6B,thereby further increasing overall flexibility and column strength ofthe flex guide 134.

In accordance with an alternative embodiment of the present invention,the catheter devices 100 and 138 may also have a guide tip 176 as shownwith reference to FIG. 6D. In this embodiment, the guide tip 176 has acircular configuration and a tip 176 a which penetrates an arterial wallof a lumen during operation of the catheter devices 100 and 138. Inaddition, the configuration of the tip 176 a minimizes the possibilityof improper penetration by the guide tip 176 during penetration of anarterial wall.

A guide tip for the catheters 100 and 138 may also have theconfiguration shown with respect to FIG. 6E. FIG. 6E illustrates aperspective view of a guide tip 178 which includes a plurality of tips178 a in accordance with an embodiment of the present invention. In thisembodiment, the plurality of tips 178 a have a circumferentialconfiguration about a periphery of the guide tip 178. Thecircumferential configuration allows proper penetration of an arterialwall of a lumen regardless of the orientation of the guide tip 178relative to the arterial wall. Thus, the circumferential configurationof the tips 178 a improves reliability and decreases overall costsassociated with a catheter device implementing the guide tip 178.

The catheter devices 100 and 138 may also be configured for anchoringwithin the subintimal space during operation of the catheter device 100,as shown with reference to FIG. 7. In this embodiment, during operationof either the catheter device 100 or 138, a user deploys a balloon 168of the catheter device 100 which anchors the catheter device 100 duringdeployment of the guide tip 132 and the flex guide 134. In thisembodiment, the balloon 168 may be any balloon suitable for anchoringthe catheter device 100 within a subintimal space of a lumen, such as apolytetrafluoroethylene (PTFE) balloon. Upon anchoring within thesubintimal space, a user deploys the guide tip 132 and the flex guide134.

In addition to the balloon 168, the catheter device 100 may also includean anchoring assembly 170 shown with reference to FIG. 8A. In thisembodiment, the anchoring assembly includes spacers 172 a and 172 b andanchors 174 as shown with respect to FIG. 8B. The anchors 174 may beconstructed of any material capable of bowing, such as nylon, silicon,C-flex® or the like. Once a user properly orientates the catheter device100 within the subintimal space of the lumen 160, the user anchors thecatheter device 100 with the anchoring assembly 170. The user anchorsthe catheter device 100 by moving the spacer 172 a in the direction X₁.As the spacers 172 a and 172 b move, the anchors 174 flex as shown withrespect to FIG. 8C. Once the anchors 174 flex, the catheter device 100has the orientation shown with reference to FIG. 8A. It should be notedthat the catheter device 138 may also employ the anchoring assembly 170for anchoring within the subintimal space of a lumen of a patient. Afterdeployment of the guide tip 132 and the flex guide 134 within a lumen apatient, a catheter may be fed over both the guide tip 132 and the flexguide 134 in order to allow blood passage around the occlusion 162.

The present invention now offers physicians performing vascularintervention an attractive alternative to direct guidewire around anocclusion within a lumen ultimately resulting in recanelization of alumen. The present invention provides surgeons with an automated methodfor incrementally and accurately deploying a guide tip within thepatient of a lumen with precision. Moreover, the present inventionprovides a hard stop during needle deployment, thereby avoiding theprior art problem of puncturing an arterial wall. Thus, the surgeonsaves the time required to accurately and precisely perform a peripheralvascular intervention procedure, thereby decreasing the overall time apatient spends in surgery and decreasing the overall costs associatedwith spending time in surgery.

The above are exemplary modes of carrying out the invention and are notintended to be limiting. It will be apparent to those of ordinary skillin the art that modifications thereto can be made without departure fromthe spirit and scope of the invention as set forth in the followingclaims.

What is claimed is:
 1. A device for advancing a guide tip through alumen, the device comprising: a catheter with the guide tip operativelyassociated with the catheter; a housing coupled with a proximal end ofthe catheter; a bushing disposed within the housing, the bushingoperatively associated with the housing and selectively engageable withan inner surface of the housing to move the bushing within the housing;an inner key coupled with the bushing and with the guide tip, the guidetip being configured to advance within the lumen and the bushing beingconfigured to move within the housing, the guide tip and the bushingbeing configured to move together; and a firing mechanism operativelyassociated with the housing and the inner key, the firing mechanismconfigure to deploy the guide tip.
 2. The device as recited in claim 1,wherein the firing mechanism comprises a safety pin and key coupled tothe safety pin.
 3. The device as recited in claim 1, further comprisinga compression spring disposed within the bushing.
 4. The device asrecited in claim 3, wherein the compression spring applies a force ofbetween 0.8 lbs and 2.5 lbs.
 5. The device as recited in claim 1,wherein the inner key includes a flange disposed within the bushing. 6.The device as recited in claim 1, further comprising a rotatable knoboperatively associated with the guide tip, wherein the guide tip isconfigured to rotate when the knob rotates.
 7. The device as recited inclaim 1, wherein the catheter further comprises a nose cone, the nosecone including a nose cone cam surface and the guide tip comprising aguide tip cam surface, the nose cone cam surface configured to engagewith the guide tip cam surface as the guide tip begins advancement intothe lumen wherein the engagement between the nose cone cam surface andthe guide tip cam surface directs penetration of the guide tip throughthe tissue surrounding the lumen.
 8. The device as recited in claim 1,wherein the guide tip is constructed of stainless steel.
 9. The deviceas recited in claim 8, the device further comprising a flex guidecoupled with the guide tip wherein the flex guide has a wall defining aslot configuration.
 10. The device as recited in claim 8, wherein theguide tip is configured to penetrate tissue surrounding the lumen.
 11. Adevice for advancing a guide tip through a lumen, the device comprising:a catheter with the guide tip operatively associated with the catheter;a housing coupled with a proximal end of the catheter; a bushingdisposed within the housing, the bushing operatively associated with thehousing and selectively engageable with an inner surface of the housingto translate the bushing longitudinally within the housing; an inner keycoupled with the bushing, the guide tip being coupled with the innerkey, the inner key being configured to advance as the bushing advances;and a firing mechanism operatively associated with the housing and theinner key, the firing mechanism comprising a safety pin and a keycoupled to the safety pin, the key selectively engaging with the innerkey to deploy the guide tip.
 12. The device as recited in claim 11,wherein rotational movement of the housing longitudinally advances thebushing.
 13. The device as recited in claim 12, further comprising acompression spring disposed within the bushing.
 14. The device asrecited in claim 13, wherein the safety pin is movable transversely tothe key.
 15. The device as recited in claim 11, wherein the inner keyextends through a keyhole in the key.
 16. The device as recited in claim15, wherein the key includes two keyholes of differing diameters.
 17. Adevice for advancing a guide tip through a lumen, the device comprising:a catheter having an anchor operatively associated with the catheter ata distal portion of the catheter; a housing coupled with a proximal endof the catheter; a bushing disposed within the housing, the bushingbeing selectively engageable with an inner surface of the housing toincrementally translate the bushing within the housing; an inner keycoupled with the bushing, the anchor being coupled with the inner key,the inner key being configured to advance as the bushing advances; and afiring mechanism operatively associated with the housing and the innerkey, the firing mechanism comprising a safety pin and a key coupled tothe safety pin, the safety pin configured to slide transversely to alongitudinal axis of the housing and release the inner key to deploy theanchor.
 18. The device as recited in claim 17, wherein the key comprisea first keyhole and a second keyhole, the first and second keyholesbeing joined together.
 19. The device as recited in claim 18, whereinthe first keyhole has a diameter smaller than the second keyhole. 20.The device as recited in claim 19, wherein the safety pin is L-shaped.21. A method for advancing a guide tip through an arterial wall defininga lumen using a catheter device, the method comprising; introducing acatheter having an inner key within a lumen of a patient on a first sideof an occlusion within the lumen, wherein the inner key couples with abushing disposed within a housing, wherein a movement of the inner keyis limited by a firing mechanism; navigating around the occlusion withinthe lumen to a second side of the occlusion with the catheter; anchoringthe catheter within tissue adjacent the lumen; activating the firingmechanism to release the inner key; and advancing the guide tip throughthe arterial wall and into the lumen on the second side of the occlusionby rotating the housing of the catheter device relative to the bushingdisposed within the housing to advance the bushing linearly within thehousing.
 22. The method as recited in claim 21, wherein activating thefiring mechanism comprises moving a safety pin relative to a key of thefiring mechanism.
 23. The method as recited in claim 22, wherein movingthe safety pin relative to the key further comprises sliding a portionof the safety pin from engagement with a keyhole of the key to releasethe inner key.
 24. The method as recited in claim 23, wherein sliding aportion of the safety pin releases the inner key to move from a firstkeyhole of the key to a second keyhole of the key.
 25. The method asrecited in claim 21, wherein anchoring the catheter within tissuecomprises deploying an anchor of an anchoring assembly, the anchorcomprising a material capable of bowing.
 26. The method as recited inclaim 21, wherein anchoring the catheter within tissue comprisesdeploying a balloon.